Who We Are:As the world's largest academic clinical research organization and part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. We are dedicated to advancing clinical research by promoting innovation, education, scientifically designed studies, and operationally efficient clinical trial conduct.

Occupational Summary

Develop, coordinate and supervise research and administrative activities of clinical research studies conducted by the Duke Early Phase Clinical Research Unit (DEPRU); develop and oversee a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Independently plan and provide professional nursing care for patients/subjects in accordance with physician orders, established policies and procedures and the research protocol. Provide nursing care services in accordance with the scope of the RN as defined by the North Carolina Board of Nursing.

Work Performed

1. Clinical research operations. Screen, schedule, consent, and collect adverse events (AE) information for participants in a variety of studies. Maintain subject level documentation, including documentation of consent in the electronic medical record. Prepare documents, equipment, or supplies for research visits. Conduct and document visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for all types of studies independently. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Evaluate processes to identify issues related to recruitment and retention rates. May provide training to personnel.

2. Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research. Train junior staff in the ethical conduct of research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.

4. Scientific concepts and research design. Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of, or develop, proposals or protocols; identify shortcomings of proposals and protocols.

5. Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. Successfully take part in or lead a committee or task force. Actively seek out continuing education opportunities for self and study team members. Participate in or lead scientific presentations and publications.

6. Study and site management. Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies. Develop protocol- specific systems and documents including process flows, training manuals, SOPs, and CRFs, Communication and team science. Prepare for and lead team meetings. Take an active role in including others in decision-making, and escalate issues appropriately.

7. Nursing activities. Plan, provide, supervise, and document professional nursing care utilizing the nursing process for patients/subjects in accordance with physician orders and established policies and procedures and research protocol. Use professional nursing judgment when conducting nursing research activities to patients.

Requisition Number401244476

LocationDurham

Duke EntityMEDICAL CENTER

Job Code1203 CLINICAL RESEARCH NURSE COORDINATOR

Job Family Level54

Exempt/Non-ExemptExempt

Full Time / Part TimeFULL TIME

Regular / TemporaryRegular

ShiftFirst/Day

Minimum QualificationsDuke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Education

Work requires graduation from an accredited BSN or Associate's Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelor's degree in Nursing (or higher) will be required to enroll in an appropriate BSN program within two years of their start date and to complete the program within five years of their start date. Must have current or compact RN licensure in the state of North Carolina. BLS required.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.